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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00620711
Other study ID # 070984
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date February 2008
Est. completion date July 2013

Study information

Verified date January 2019
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The hypothesis is that premature infants' can have enough cooling applied to cool their brain to decrease CNS injury without cooling their body.


Description:

Hypoxic ischemic encephalopathy (HIE) is a potentially devastating disease of the newborn central nervous system (CNS) . Portions of the CNS are deprived of oxygen and blood flow for a period of time which may lead to permanent brain injury manifested as cerebral palsy as well as cognitive defects. Until recently no treatment has been shown to be effective for preventing brain damage, even though it has been demonstrated that the damage is progressive and that there is a window of opportunity to arrest some of the evolving brain injury. However, in May of 2007 the FDA approved the first device specifically designed to ameliorate brain damage in term babies with HIE. This head cooling device which was studied here at Vanderbilt under IRB protocol 990129 Brain Cooling for the treatment of perinatal hypoxic ischemic encephalopathy. We thus have eight years of experience of using this device in term infants. The results of the initial trial demonstrated a successful reduction of HIE induced brain injury from 66% in control infants to 55% in treated babies. There were no significant risks to the application of this device in term babies who are kept cool for 72 hours after experiencing an acute HIE event. The initial trials were limited to term babies because of concern that premature infants would be more at risk for hypothermia induced problems such as hypoglycemia,and coagulopathy. The concern about hypothermia in preterm infants remains a limiting consideration for doing whole body cooling in this population. We propose to apply the cooling cap to the heads of preterm infants who have experienced a significant HIE injury but maintain their body temperature in the normal range (36.1-37° C rectally). Infants will be cooled for up to 72 hours and will be tracked till discharge. Although this is a feasibility study, the participants will also be followed-up at 6, 12 and 24 months of age.


Recruitment information / eligibility

Status Completed
Enrollment 4
Est. completion date July 2013
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender All
Age group N/A to 6 Hours
Eligibility Inclusion Criteria:

- Babies < 36 weeks gestation but > 32 0/7 weeks. These babies should be small enough to allow brain cooling with water circulating in a cooling cap applied to the surface of their head

- At least one of the following four criteria which are standard definitions for HIE:

- Apgar 0-3 at 1,5,10 minutes due to hypoxia

- pH less than 7.0

- Base deficit greater than 15

- Need for continued resuscitation due to hypoxia at 10 minutes

- AND a physical exam with evidence of hypotonia or lethargy or seizures indicative of evolving HIE.

- Intubated

- Age less than 6 hours

- Signed informed consent by parent / legal guardian

- Previous participant has been followed through 7 day head ultrasound.

Exclusion Criteria:

- Mild HIE will not be cooled, therefore babies without hypotonia or lethargy and babies who are not intubated will be excluded.

- Gestational age = 36 weeks or < 32 weeks or less than 1200 grams.

- Older than 6 hours of age

- Infant deemed in extremis on clinical exam.

- Survival not expected, i.e. received 3 intravenous doses of epinephrine or more during resuscitation; on infusion of dopamine, dobutamine and/or epinephrine at time of evaluation; and/or has fixed/dilated pupils.

- Evidence of head trauma or skull fracture causing major intracranial hemorrhage

- Intraventricular hemorrhage

- Weight less than the 5th percentile for gestational age

- Refusal of consent

- Imperforate anus

Study Design


Intervention

Device:
Olympic Cool Cap
Olympic Cool Cap will be applied to infants 32-35 weeks gestation who meet criteria for HIE.

Locations

Country Name City State
United States Monroe Carell Jr Children's Hospital Nashville Tennessee

Sponsors (1)

Lead Sponsor Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility Trial- the Olympic Cool Cap Will be Applied, Can the Delivered Cap Temperature be Less Than 12 Degrees Without Changing Rectal Temperature. Measurement of number of participants able to obtain 12 degree cap temperature 60 minutes intervals up to 72 hours
Primary Cap Cooled to 12 Degrees Without Reducing Rectal Temperature Yes/no 6 hours
See also
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Completed NCT01471015 - Darbe Administration in Newborns Undergoing Cooling for Encephalopathy Phase 1/Phase 2
Completed NCT01481207 - Magnetic Resonance Imaging and Spectroscopy Biomarkers of Neonatal Hypoxic Ischemic Encephalopathy
Completed NCT01649648 - Autologous Cord Blood Cells for Brain Injury in Term Newborns Phase 1
Withdrawn NCT00993564 - Magnetic Resonance Imaging (MRI) Thermal Imaging of Infants Undergoing Cooling for Hypoxic Ischemic Encephalopathy (HIE) N/A
Completed NCT00945789 - Erythropoietin in Infants With Hypoxic Ischemic Encephalopathy (HIE) Phase 1/Phase 2
Completed NCT00097097 - Neonatal Resuscitation in Zambia Phase 3
Recruiting NCT02621944 - Melatonin as a Neuroprotective Therapy in Neonates With HIE Undergoing Hypothermia Early Phase 1
Not yet recruiting NCT02605018 - Neuroprotective Effect of Autologous Cord Blood Combined With Therapeutic Hypothermia Following Neonatal Encephalopathy Phase 1/Phase 2
Withdrawn NCT01128673 - MRI Thermal Imaging of Infants Undergoing Cooling for Hypoxic Ischemic Encephalopathy(HIE) N/A
Completed NCT01732146 - Efficacy of Erythropoietin to Improve Survival and Neurological Outcome in Hypoxic Ischemic Encephalopathy Phase 3
Completed NCT02349672 - Clinical Utility of Serum Biomarkers for the Management of Neonatal Hypoxic Ischemic Encephalopathy (Control Levels)
Completed NCT02826941 - Moderate Hypothermia in Neonatal Hypoxic Ischemic Encephalopathy Phase 2
Active, not recruiting NCT01138176 - Whole Body Cooling Using Phase Changing Material Phase 1/Phase 2
Recruiting NCT02578823 - Targeted Temperature Management After In-Hospital Cardiac Arrest N/A
Terminated NCT01765218 - Topiramate in Neonates Receiving Whole Body Cooling for Hypoxic Ischemic Encephalopathy Phase 1/Phase 2
Completed NCT01241019 - Safety and Efficacy of Topiramate in Neonates With Hypoxic Ischemic Encephalopathy Treated With Hypothermia Phase 2